In the medical field, contamination control finds its applications in areas of high infection risk. The use of laminar flow facilities and systems for the control of airborne biocontamination provides a concrete contribution to the creation of technologically advanced environments necessary for the application of complex therapies. ASSING offers a complete service from design to implementation and management of hospital facilities, operating rooms and sterile blocks, laminar flow systems, special intensive care units and isolation of infectious or immunocompromised patients, “CELL-FACTORY” Laboratories for Advanced Regenerative Therapies: Cell Therapy, Gene Therapy, Tissue Engineering.
Life Science Applications
The following areas of focus are included in this category:
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CELL-FACTORY AND BIOBANKS FOR ADVANCED THERAPIES
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HOSPITAL PHARMACY DEPARTMENTS (UFA AND RADIFARMACEUTICALS)
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PATIENT ISOLATION WARDS
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OPERATING ROOMS AND STERILE BLOCKS
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LAMINAR FLOW SYSTEMS
- SPECIAL INTENSIVE CARE UNITS
A complete package of services tailored to your needs
- Analysis of production process and specifications for achieving the required degree of protection for product and operator
- Identification of process layouts and analysis of critical points
- Determination of contamination classes of affected areas according to international standards (GMP – FDA – ISO)
- Planivolumetric study of the building and determination of energy needs
- Analysis of necessary machinery and utilities
- Development of preliminary design and economic analysis of investments
- Analysis of production processes
- Definition of material and personnel flows
- Process layout
- Identification of air contamination control issues according to required classes
- Study and sizing of air conditioning and filtration (HVAC) systems and utilities
- Study of electrical, control, supervisory and safety systems
- Definition of suitable materials for civil finishes with low particle release infrastructure
- Drafting of specifications for contracts
- Detailed executive design of air conditioning systems, electrical systems, automation and supervision systems, civil infrastructure
- Issuance of technical specifications and material requirements
- Job order planning, control and management
- Construction management
- Supply and implementation of turnkey facilities
- Planning, coordination and management of contract and site work
- Technical supervision and construction management
- Resource management and job order cost control
- Plant startup and balancing
- Testing
- “as built” documentation
- Electrical and HVAC system certifications
- Class certifications according to ISO 14644
- Performance of IQ-OQ-PQ Validation Tests
- Preparation of operating manuals
- Operation service and scheduled preventive maintenance
- Technical service and spare parts
- Staff training courses on cleanroom operation and behavior
- Consulting in the drafting of SOPs